Ertugliflozin Type 2 Diabetes Mellitus (T2DM) Pediatric S... | NCT04029480

NCT04029480

ID	Type	Description
PHRR190913-002184	Registry Identifier	PHRR
2022-501085-21-00	Registry Identifier	EU CT
U1111-1279-3984	Registry Identifier	UTN
MK-8835-059	Other Identifier	MSD
2017-003455-35	EudraCT Number

Status Module

Name	Class
Pfizer	INDUSTRY

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ertugliflozin 5 mg	Experimental	All participants initially received 5 mg ertugliflozin (ERTU) once daily (QD) and placebo to 15 mg ERTU QD until Week 54 (WK54). At Week 12 (WK12), participants who did not meet the up-titration criteria remained on 5 mg ERTU and placebo to 15 mg ERTU. Participants remained on their background metformin with/without insulin treatment throughout the study.	Drug: Ertugliflozin 5 mg Drug: Placebo to ertugliflozin 15 mg Biological: Insulin Drug: Metformin
Ertugliflozin 5 mg/5 mg	Experimental	All participants initially received 5 mg ERTU QD and placebo to 15 mg ERTU QD until Week 12. Participants remained on their background metformin with/without insulin treatment throughout the study. Participants who met the up-titration criteria at the WK12 second randomization were re-randomized to remain on 5 mg ERTU and placebo to 15 mg ERTU from WK12 to WK54.	Drug: Ertugliflozin 5 mg Drug: Placebo to ertugliflozin 15 mg Biological: Insulin Drug: Metformin
Ertugliflozin 5 mg/15 mg	Experimental	All participants initially received 5 mg ERTU QD and placebo to 15 mg ERTU QD until Week 12. Participants remained on their background metformin with/without insulin treatment throughout the study. Participants who met the up-titration criteria at the WK12 second randomization were up-titrated to 15 mg ERTU and placebo to 5 mg ERTU from WK12 to WK54.	Drug: Ertugliflozin 5 mg Drug: Ertugliflozin 15 mg Drug: Placebo to ertugliflozin 15 mg Drug: Placebo to ertugliflozin 5 mg Biological: Insulin Drug: Metformin

Name	Type	Description	Arm Group Labels	Other Names
Ertugliflozin 5 mg	Drug	Ertugliflozin 5 mg, oral, 1 tablet QD	Ertugliflozin 5 mg Ertugliflozin 5 mg/15 mg Ertugliflozin 5 mg/5 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Hemoglobin A1C (HbA1C) at Week 24 (Combined Ertugliflozin Versus Placebo)	Hemoglobin A1C is a measure of the percentage of glycated HbA1C in the blood. Participant whole blood samples were collected at baseline and Week 24 to determine the A1C change from baseline (i.e., % A1C at Week 24 minus % A1C at baseline). A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication. The Bayesian mean change from baseline for each combined ertugliflozin and placebo are reported. Per protocol, the ertugliflozin arms are combined for this analysis.	Baseline and Week 24
Number of Participants Who Experienced an Adverse Event (AE) Up to Week 24	An adverse event -- Select --is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. Per protocol, the ertugliflozin arms are combined for this analysis.	Up to Week 24
Number of Participants Who Experienced an AE Up to Week 54	An adverse event is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. Per protocol, the ertugliflozin arms are combined for this analysis.	Up to Week 54
Number of Participants Who Discontinued Study Treatment Due to an AE Up to Week 24

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in Hemoglobin A1C at Week 24 (Dose-optimized Ertugliflozin Versus Placebo)	Hemoglobin A1C is a measure of the percentage of glycated HbA1C in the blood. Participant whole blood samples were collected at baseline and Week 24 to determine the A1C change from baseline (i.e., % A1C at Week 24 minus % A1C at baseline). A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

Be ≥10 years and ≤17 years of age, when the informed consent is signed
Has diabetes diagnosed by one of the American Diabetes Association (ADA) criteria.
Has body mass index (BMI) ≥85th percentile at screening OR participant has a history of being overweight or obese at time of diagnosis of Type 2 diabetes mellitus (T2DM).
T2DM for ≥2 years, OR T2DM for <2 years and a fasting C-peptide value >0.6 ng/mL at Screening.
On stable metformin monotherapy (≥1500 mg/day, for ≥8 weeks prior to Screening, OR on a stable metformin dose (≥1500 mg/day, for ≥8 weeks prior to Screening and a stable dose of insulin for ≥8 weeks prior to Screening.
Contraceptive use by male participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Is a non-sterilized female who is currently not sexually active OR who agrees to abstain from heterosexual activity OR who agrees to start contraception prior to initiating sexual activity and who agrees to use an adequate method of contraception. Contraceptive use by females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Have a family member or adult who, along with the participant, will be closely involved in the participant's daily activities (in the opinion of the investigator) and in the participant's treatment and study procedures.

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

Has known type 1 diabetes mellitus or documented evidence of positive diabetes autoantibodies performed when participant was diagnosed with diabetes.
Has known monogenic diabetes, or secondary diabetes.
Has symptomatic hyperglycemia and/or moderate to large ketonuria requiring immediate initiation of another antihyperglycemic agent, including insulin.
Has a known hypersensitivity or intolerance to any sodium glucose co-transporter 2 (SGLT2) inhibitor.
Is pregnant, or breast feeding or is expecting to conceive or donate eggs during the study, including 14 days following the last dose of study medication.
Has previously taken an SGLT2 inhibitor (such as canagliflozin, dapagliflozin, empagliflozin, or ertugliflozin) or was enrolled in a study for these agents.
Has a history of idiopathic acute pancreatitis or chronic pancreatitis.
Has a history of severe hypoglycemia while on insulin.

Name	Affiliation	Role
Medical Director	Merck Sharp & Dohme LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
The University of Alabama at Birmingham ( Site 2207)		Birmingham	Alabama	35233-1711	United States

Label	URL
Plain Language Summary	View source
Merck Clinical Trials Information	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	5 mg Ertugliflozin	Participants received 5 mg ertugliflozin (ERTU) once daily (QD) and placebo to 15 mg ERTU QD until Week 54 (WK54). At Week 12 (WK12), participants who did not meet the up-titration criteria remained on 5 mg ERTU and placebo to 15 mg ERTU. Participants remained on their background metformin with/without insulin treatment throughout the study.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Nov 14, 2024

Arm/Group Information

ID	Title	Description
BG000	5 mg Ertugliflozin	Participants received 5 mg ertugliflozin (ERTU) once daily (QD) and placebo to 15 mg ERTU QD until Week 54 (WK54). At Week 12 (WK12), participants who did not meet the up-titration criteria remained on 5 mg ERTU and placebo to 15 mg ERTU. Participants remained on their background metformin with/without insulin treatment throughout the study.
BG001	5 mg/5 mg Ertugliflozin	Participants initially received 5 mg ERTU QD and placebo to 15 mg ERTU QD until WK12. Participants remained on their background metformin with/without insulin treatment throughout the study. Participants who met the up-titration criteria at the WK12 second randomization were re-randomized to remain on 5 mg ERTU and placebo to 15 mg ERTU from WK12 to WK54.
BG002	5 mg/15 mg Ertugliflozin	Participants initially received 5 mg ERTU QD and placebo to 15 mg ERTU QD until WK12. Participants remained on their background metformin with/without insulin treatment throughout the study. Participants who met the up-titration criteria at the WK12 second randomization were up-titrated to 15 mg ERTU and placebo to 5 mg ERTU from WK12 to WK54.
BG003	Placebo	Participants received matched placebo to 5 mg ERTU and 15 mg ERTU from baseline to WK54. Participants remained on their background metformin with/without insulin treatment throughout the study.
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00014.4± 2.0 BG00114.6± 2.0 BG00215.6± 1.8 BG003

Age, Customized

Per protocol, all participants were randomized before their 18th birthday. Ages from baseline (Day 1) are reported. Participants may show as ≥18 years of age since to protect participant privacy, only the month and year of birth were collected and an imputed date (first of the month) was used to calculate ages in the baseline characteristics; however, each participant was confirmed to be <18 years of age at the time of randomization.

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
In utero	BG0000 BG001

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00038 BG00110 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00033 BG0018 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0006 BG0013 BG002

Baseline A1C

Hemoglobin A1C is a measure of the percentage of glycated HbA1C in the blood. Participant whole blood samples were collected at baseline to measure A1C. All participants randomized were included in the analysis.

Mean

Standard Deviation

A1C Percentage

Title

Denominators

Categories

Title	Measurements
	BG0007.6± 1.0 BG001

Insulin Use at Screening

Participant insulin use at screening was assessed. All participants randomized were included in the analysis.

Count of Participants

Participants

Title

Denominators

Categories

Yes

Title	Measurements
	BG00018 BG00114

Age at Screening

The participant age at screening was collected in order to stratify participants at the first randomization.

Number

Years

Title

Denominators

Categories

10 to 14 years of age

Title	Measurements
	BG00027 BG00111 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline in Hemoglobin A1C (HbA1C) at Week 24 (Combined Ertugliflozin Versus Placebo)

Hemoglobin A1C is a measure of the percentage of glycated HbA1C in the blood. Participant whole blood samples were collected at baseline and Week 24 to determine the A1C change from baseline (i.e., % A1C at Week 24 minus % A1C at baseline). A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication. The Bayesian mean change from baseline for each combined ertugliflozin and placebo are reported. Per protocol, the ertugliflozin arms are combined for this analysis.

This analysis includes all participants who received at least 1 dose of study treatment and excludes data following initiation of rescue therapy as well as data collected more than 5 days after the discontinuation of study medication.

Posted

Least Squares Mean

95% Confidence Interval

A1C Percentage

Baseline and Week 24

ID	Title	Description
OG000	Combined Ertugliflozin	Participants who received at least 1 dose of ertugliflozin.
OG001	Placebo	Participants received matched placebo to 5 mg ERTU and 15 mg ERTU from baseline to WK54. Participants remained on their background metformin with/without insulin treatment throughout the study.

Units	Counts
Participants	OG000111 OG00155

Title

Denominators

Categories

Title	Measurements
	OG000-0.55(-0.82 to -0.28) OG0010.12(-0.23 to 0.47)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	This analysis is based on a Bayesian ANCOVA model including terms for Baseline A1C, treatment, age (10 to 14 years/15 to 17 years), and insulin use (yes/no) at Screening and calculated by Rubin's Rule. The 95% confidence interval actually refers to a credible interval.					Difference in Bayesian Means	-0.67			2-Sided	95	-1.06	-0.29					Superiority

Primary

Number of Participants Who Experienced an Adverse Event (AE) Up to Week 24

An adverse event -- Select --is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. Per protocol, the ertugliflozin arms are combined for this analysis.

The analysis population includes all randomized participants who received at least one dose of study treatment.

Posted

Count of Participants

Participants

Up to Week 24

ID	Title	Description
OG000	Combined Ertugliflozin	Participants who received at least 1 dose of ertugliflozin.
OG001	Placebo	Participants received matched placebo to 5 mg ERTU and 15 mg ERTU from baseline to WK54. Participants remained on their background metformin with/without insulin treatment throughout the study.

Units	Counts

Primary

Number of Participants Who Experienced an AE Up to Week 54

An adverse event is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. Per protocol, the ertugliflozin arms are combined for this analysis.

The analysis population includes all randomized participants who received at least one dose of study treatment.

Posted

Count of Participants

Participants

Up to Week 54

ID	Title	Description
OG000	Combined Ertugliflozin	Participants who received at least 1 dose of ertugliflozin.
OG001	Placebo	Participants received matched placebo to 5 mg ERTU and 15 mg ERTU from baseline to WK54. Participants remained on their background metformin with/without insulin treatment throughout the study.

Units	Counts

Primary

Number of Participants Who Discontinued Study Treatment Due to an AE Up to Week 24

The analysis population includes all randomized participants who received at least one dose of study treatment up.

Posted

Count of Participants

Participants

Up to Week 24

ID	Title	Description
OG000	Combined Ertugliflozin	Participants who received at least 1 dose of ertugliflozin.
OG001	Placebo	Participants received matched placebo to 5 mg ERTU and 15 mg ERTU from baseline to WK54. Participants remained on their background metformin with/without insulin treatment throughout the study.

Units	Counts

Primary

Number of Participants Who Discontinued Study Treatment Due to an AE Up to Week 54

The analysis population includes all randomized participants who received at least one dose of study treatment up.

Posted

Count of Participants

Participants

Up to Week 54

ID	Title	Description
OG000	Combined Ertugliflozin	Participants who received at least 1 dose of ertugliflozin.
OG001	Placebo	Participants received matched placebo to 5 mg ERTU and 15 mg ERTU from baseline to WK54. Participants remained on their background metformin with/without insulin treatment throughout the study.

Units	Counts

Secondary

Change From Baseline in Hemoglobin A1C at Week 24 (Dose-optimized Ertugliflozin Versus Placebo)

This analysis includes all participants who were randomized to ertugliflozin and either did not meet the re-randomization criteria at Week 12 or were re-randomized to ertugliflozin 15 mg, took at least 1 dose of study treatment, and includes all data following initiation of rescue therapy as well as data collected after the discontinuation of study medication.

Posted

Least Squares Mean

95% Confidence Interval

A1C Percentage

Baseline and Week 24

ID	Title	Description
OG000	Dose-Optimized Ertugliflozin	Participants who were randomized to ertugliflozin and either did not meet the re-randomization criterion at Week 12 or were re-randomized to 15 mg ertugliflozin.
OG001	Placebo	Participants received matched placebo to 5 mg ERTU and 15 mg ERTU from baseline to WK54. Participants remained on their background metformin with/without insulin treatment throughout the study.

Secondary

Change From Baseline in Hemoglobin A1C at Week 24 (5 mg Ertugliflozin Versus Placebo)

This analysis includes all participants randomized to ertugliflozin and either did not meet the re-randomization criteria at Week 12 or were re-randomized to 5 mg ertugliflozin, and all data following initiation of rescue therapy as well as data collected after the discontinuation of study medication.

Posted

Least Squares Mean

95% Confidence Interval

A1C Percentage

Baseline and Week 24

ID	Title	Description
OG000	5 mg Ertuglifozin	Participants who were randomized to ertugliflozin and either did not meet the re-randomization criterion at Week 12 or were re-randomized to 5 mg ertugliflozin.
OG001	Placebo	Participants received matched placebo to 5 mg ERTU and 15 mg ERTU from baseline to WK54. Participants remained on their background metformin with/without insulin treatment throughout the study.

Secondary

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24

Blood glucose is measured on a fasting basis. FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 24 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 24 minus FPG at baseline). A negative number indicates a reduction in FPG. Participants who met glycemic rescue criteria received glycemic rescue medication. Per protocol, the ertugliflozin arms were combined for this analysis.

Posted

Least Squares Mean

95% Confidence Interval

mg/dL

Baseline and Week 24

ID	Title	Description
OG000	Combined Ertugliflozin	Participants who received at least 1 dose of ertugliflozin.
OG001	Placebo	Participants received matched placebo to 5 mg ERTU and 15 mg ERTU from baseline to WK54. Participants remained on their background metformin with/without insulin treatment throughout the study.

Units	Counts

Secondary

Change From Baseline in Hemoglobin A1C at Week 54

Hemoglobin A1C is a measure of the percentage of glycated HbA1C in the blood. Participant whole blood samples were collected at baseline and Week 54 to determine the A1C change from baseline (i.e., A1C at Week 54 minus A1C at baseline). A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication. Per protocol, the ertugliflozin arms were combined for this analysis.

Posted

Least Squares Mean

95% Confidence Interval

AIC Percentage

Baseline and Week 54

ID	Title	Description
OG000	Combined Ertugliflozin	Participants who received at least 1 dose of ertugliflozin.
OG001	Placebo	Participants received matched placebo to 5 mg ERTU and 15 mg ERTU from baseline to WK54. Participants remained on their background metformin with/without insulin treatment throughout the study.

Units	Counts

Secondary

Change From Baseline in FPG at Week 54

Blood glucose is measured on a fasting basis. FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 54 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 54 minus FPG at baseline). A negative number indicates a reduction in FPG. Participants who met glycemic rescue criteria received glycemic rescue medication. Per protocol, the ertugliflozin arms were combined for this analysis.

Posted

Least Squares Mean

95% Confidence Interval

mg/dL

Baseline and Week 54

ID	Title	Description
OG000	Combined Ertugliflozin	Participants who received at least 1 dose of ertugliflozin.
OG001	Placebo	Participants received matched placebo to 5 mg ERTU and 15 mg ERTU from baseline to WK54. Participants remained on their background metformin with/without insulin treatment throughout the study.

Units	Counts

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	5 mg Ertugliflozin: Week 1-54	Participants received 5 mg ertugliflozin (ERTU) once daily (QD) and placebo to 15 mg ERTU QD until Week 54 (WK54). At Week 12 (WK12), participants who did not meet the up-titration criteria remained on 5 mg ERTU and placebo to 15 mg ERTU. Participants remained on their background metformin with/without insulin treatment throughout the study.	63	2	63	29	63
EG001	5 mg/5 mg Ertugliflozin: Week 1-54	Participants initially received 5 mg ERTU QD and placebo to 15 mg ERTU QD until WK12. Participants remained on their background metformin with/without insulin treatment throughout the study. Participants who met the up-titration criteria at the WK12 second randomization were re-randomized to remain on 5 mg ERTU and placebo to 15 mg ERTU from WK12 to WK54.	22	1	22	11	22
EG002	5 mg/15 mg Ertugliflozin: Week 1-12 (Ertu 5 mg)	After the first randomization on Day 1, participants received 5mg ERTU QD and placebo to 15 mg ERTU QD until WK12. Participants remained on their background metformin with/without insulin treatment throughout the study.	26	0	26	8	26
EG003	5 mg/15 mg Ertugliflozin: Week 12-54 (Ertu 15 mg)	After the second randomization at WK12, participants received 15mg ERTU QD and placebo to 5 mg ERTU QD from WK12 to WK54. Participants remained on their background metformin with/without insulin treatment throughout the study.	26	1	26	14	26
EG004	Placebo: Week 1-54	Participants received matched placebo to 5 mg ERTU and 15 mg ERTU from baseline to WK54. Participants remained on their background metformin with/without insulin treatment throughout the study.	55	0	55	31	55

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
COVID-19 pneumonia	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected63 at risk EG0011 events1 affected22 at risk EG0020 events0 affected26 at risk EG0030 events0 affected26 at risk EG0040 events0 affected55 at risk
Post procedural infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected63 at risk EG0010 events0 affected22 at risk EG0020 events0 affected26 at risk EG003
Foot fracture	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected63 at risk EG0010 events0 affected22 at risk EG0020 events0 affected26 at risk EG003
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected63 at risk EG0010 events0 affected22 at risk EG0020 events0 affected26 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected63 at risk EG0010 events0 affected22 at risk EG0020 events0 affected26 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected63 at risk EG0010 events0 affected22 at risk EG0020 events0 affected26 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected63 at risk EG0012 events2 affected22 at risk EG0021 events1 affected26 at risk EG0032 events2 affected26 at risk EG0046 events3 affected55 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected63 at risk EG0013 events2 affected22 at risk EG0020 events0 affected26 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0005 events4 affected63 at risk EG0010 events0 affected22 at risk EG0020 events0 affected26 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected63 at risk EG0013 events3 affected22 at risk EG0022 events2 affected26 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0002 events1 affected63 at risk EG0012 events2 affected22 at risk EG0022 events2 affected26 at risk EG003
Pyrexia	General disorders	MedDRA 27.1	Systematic Assessment	EG0004 events4 affected63 at risk EG0011 events1 affected22 at risk EG0021 events1 affected26 at risk EG003
COVID-19	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0005 events5 affected63 at risk EG0012 events1 affected22 at risk EG0020 events0 affected26 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0003 events3 affected63 at risk EG0010 events0 affected22 at risk EG0020 events0 affected26 at risk EG003
Influenza	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0005 events4 affected63 at risk EG0010 events0 affected22 at risk EG0021 events1 affected26 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0006 events5 affected63 at risk EG0011 events1 affected22 at risk EG0020 events0 affected26 at risk EG003
Pharyngitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected63 at risk EG0012 events2 affected22 at risk EG0020 events0 affected26 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG00011 events9 affected63 at risk EG0011 events1 affected22 at risk EG0021 events1 affected26 at risk EG003
Urine albumin/creatinine ratio increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected63 at risk EG0010 events0 affected22 at risk EG0020 events0 affected26 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected63 at risk EG0015 events1 affected22 at risk EG0020 events0 affected26 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG00035 events7 affected63 at risk EG0013 events2 affected22 at risk EG00212 events3 affected26 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected63 at risk EG0010 events0 affected22 at risk EG0020 events0 affected26 at risk EG003
Dizziness	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected63 at risk EG0010 events0 affected22 at risk EG0020 events0 affected26 at risk EG003
Headache	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0005 events5 affected63 at risk EG0011 events1 affected22 at risk EG0021 events1 affected26 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected63 at risk EG0010 events0 affected22 at risk EG0020 events0 affected26 at risk EG003

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D011384	Proinsulin
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals